Tampon leakage typically ranges from about 15% to about 20% incidence of tampon leakage for all sizes of tampons. Most leakage is attributed to the bypass of blood or other body fluids from the vagina during menstruation, such bypass being due to a less-than-optimal fit of the tampon within the vagina. The propensity of any commercially-produced tampon to leak is highly unpredictable due to tampons being mass produced and further due to wide anatomical variations among users. Both MRI (magnetic resonance imaging) analysis with actual users as well as ION simulations (anthropometrically correct simulation devices) indicate that a higher likelihood of bypass leakage exists when the tampon is inserted high into the vaginal canal and angled to either the right or left side of the fornices of the vagina.
As is shown in FIGS. 1A and 1B, the approximate location of a typical tampon 10 inserted into a vagina 12 through a tampon applicator 15 is shown. The tampon 10 is a Regular absorbency tampon as defined by the FDA. As used herein, the term “Regular” with regard to tampons means a tampon having a dry width of about 0.48 inches. In FIG. 1A, the tampon 10 is inserted into the vagina using an applicator into a “high” position, which means the tampon is inserted farther than is required to provide for the suitable absorption of body fluids. As shown, the tampon 10 is in a dry state (i.e., before the absorption of a significant amount of body fluid). When inserted to this position, which is about 2 inches beyond the introitus 14, the tampon 10 is angled to one side of the fornices (not shown) such that gaps 16 are defined between the sides and edges of the tampon and at least some of the wall of the vagina 12. These gaps 16 undesirably allow for the flow of body fluids past the tampon 10.
In FIG. 1B, the tampon 10 is again illustrated in the dry state and is inserted into the vagina 12 into a “low” position using the applicator (shown at 15). In the low position, the tampon is inserted to just inside the introitus 14 about 1.25 inches. When inserted to this position, gaps 16 are defined between the sides and edges of the tampon 10 and the wall of the vagina 12. The gaps 16 undesirably allow for the flow of body fluids past the tampon 10.
In FIGS. 2A and 2B, the approximate location of the Regular tampon 10 inserted into the vagina 12 through a tampon applicator 15 into the high position is again shown. In FIG. 2A, the tampon 10 is in an expanded state (i.e., after the absorption of a significant amount of body fluid). When inserted to this position (again about 2 inches beyond the introitus 14), the tampon 10 is again angled to one side of the fornices. However, even in the absorbed state in which the material of the tampon 10 blooms or expands upon contact with body fluids, gaps 16 are still defined between sides 18 of the tampon 10 and the wall of the vagina 12 and undesirably allow for the flow of body fluids past the tampon.
In FIG. 2B, the tampon 10 is again illustrated in the expanded state, but it is inserted into the vagina 12 into the low position. Even with blooming of the tampon 10, the sides 18 of the tampon do not close off the gaps 16 defined between the tampon and the wall of the vagina 12.
As is shown in FIGS. 3A and 3B, the approximate location of a typical Super absorbency (as defined by FDA regulations) tampon 20 inserted into the vagina 12 through a tampon applicator 15 is shown. The tampon 20 is shown in the expanded state. As used herein, the term “Super” with regard to tampons means a tampon having a dry width of about 0.54 inches. In FIG. 3A, the tampon 20 is inserted high into the vagina 12 and is angled to one side of the fornices. Even though the tampon 20 is of the Super configuration, gaps 16 are defined between the bloomed outer surfaces of the tampon and the wall of the vagina 12. In FIG. 3B, when the tampon 20 is inserted into the vagina 12 in the low position, the gaps are eliminated or at least significantly reduced, particularly after blooming. However, movement on the part of the user may cause the tampon 20 to shift in the vagina 12, thereby causing the outer surfaces of the tampon to be spaced from the wall of the vagina, thereby further allowing leakage to occur around the tampon. Larger sizes of the tampon (e.g., “Super Plus” absorbency) may alleviate some of the problem; however, it is still possible and likely that gaps would be formed.
Given the above-described problems with tampons, it is contemplated that users would prefer tampon products with improved absorption capabilities to avoid by-pass leakage. Also, if additional protection features were incorporated into the tampon design, users would feel that they have a “second line of defense” against leakages, thereby giving them more control over their period. The present invention meets these needs.